Deadline for submission of applications: 30/09/2017
Reference: 09/2017
Number of vacancies: 1
Offer description:
Background
Quality Assurance ensures that a product or service meets the established standards of quality including reliability, usability and performance. VHIO´s Clinical Research Program, incorporating multidisciplinary cancer teams, is dedicated to developing both novel agents directed to specific signaling pathways in cancer and novel/redefined tools to diagnose cancer earlier and better predict response to therapy. We pioneer important studies involving both preclinical and early-drug development research studies and lead several phase I, II and III clinical trials designed to identify more effective, cancer therapies tailored to individual patients.
Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. To guarantee accuracy and integrity of clinical data, it is necessary to thoroughly review these data, assess the validity of outlying data points, and carefully document query identification and resolution throughout a study’s duration.
Maintaining accuracy and quality throughout a clinical trial is a continual, dynamic process. Although study requirements are carefully outlined initially in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during a study. This ongoing process requires revising mechanisms and communicating these revisions clearly to all investigators and support staff.
Requirements (degree, experience, additional training):
We seek
A Quality Assurance Technician with experience in clinical trials, preferably a Bachelor´s degree, knowledge of GCP (Good Clinical Practice), experience in quality inspection, auditing and testing as well as implementing corrective action programs. The successful candidate will also have excellent computer skills (Microsoft Office and databases), knowledge of QA tools, concepts, methodologies and relevant regulatory requirements.
Key Competencies
The following competencies will also be favorably considered:
• Attention to detail
• Good verbal and written communicator
• Data collection and management
• Excellent analytical skills with the ability to problem solve and take decisions
• Good planning and organizational skills
• Customer service orientated
• Team player
Main Roles and Responsibilities
Draft quality assurance policies and procedures
Interpretation and implementation of quality assurance standards
Evaluate adequacy of quality assurance standards
Devise sampling procedures and indications for recording and reporting quality data
Review the implementation and efficiency of quality and inspection systems
Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
Document internal audits and other quality assurance activities
Investigate customer complaints and non-conformance issues
Collect and compile statistical quality data
Analyze data to identify areas for improvement in the quality system
Develop, recommend and monitor corrective and preventive actions
Prepare reports to communicate outcomes of quality activities
Identify training needs and organize training interventions to meet quality standards
Coordinate and support on-site audits conducted by external providers
Evaluate audit findings and implement appropriate corrective actions
Monitor risk management activities
Manage document management systems
Guarantee ongoing compliance with quality and industry regulatory requirements
Additional Information:
Established in 2006, the Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain, is a leading comprehensive cancer center of excellence where its researchers and physician-scientists adopt a purely translational research model, working together as multidisciplinary teams to both accelerate and advance personalized and targeted therapies against cancer. Undertaking one of Spain’s most dynamic cancer research programs, VHIO is dedicated to delivering on the promise of precision medicine in oncology – turning cancer discovery into more effective, tailored treatments and better practice for the care of our patients.
VHIO Provides:
A dynamic, multidisciplinary research environment, optimal laboratory space and access to our cutting-edge core technologies: Cancer Genomics, Molecular Oncology, Translational Genomics, and Proteomics which are not only responsible for the development of VHIO’s core technologies and platforms but also pursue, implement and develop their own independent research lines and projects.
Located in the stunning city that is Barcelona, our exceptional facilities also comprise a state-of-the-art animal facility with a dedicated surface area of 1347 m2 and a capacity of 5471 cages. To discover more about VHIO, it’s Faculty, research programs and activities visit: www.vhio.net.
Where to apply::RRHH – selecciorrhh@vhio.net
